Lipoic Acid Injectable Recalled for Sterility Concerns
The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility concerns in injectable products which pose a risk of serious injury.
Plain-English summary
The Compounding Shop, Inc. is recalling Lipoic Acid 25 mg/mL Injectable, 100 mL vials. The recall involves 55 vials distributed to locations in Florida, California, Minnesota, and Maine. All lots of the product are affected.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and a lack of assurance of sterility. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers and healthcare providers who have this product should stop using it and contact The Compounding Shop, Inc. for further instructions or a return.
The recalled product
- Product
- Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 25 products in this recall →Related recalls
Same manufacturer · THE COMPOUNDING SHOP, INC.
See all →- SevereFDA Recalls Glutathione Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereTestosterone Cypionate Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereCompounded Injectable MIC Plus B12 Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereFDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereMethotrexate Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29